TY - JOUR
T1 - Natrelle silicone breast implant follow-up study
T2 - Demographics, lifestyle, and surgical characteristics of more than 5000 reconstruction subjects
AU - Picha, George J.
AU - Singh, Navin
AU - Murphy, Diane K.
N1 - Funding Information:
Disclosure: Dr. Picha is an employee of American Medical Technology, Applied Medical Technology, and Abeon Medical; serves as a consultant and advisory board member for Allergan, Inc.; is a member of the Data and Safety Monitoring Board (DSMB) for the BIFS-001 study; serves as an advisor for Intellirod and Mutual Capital Partners; and is an advisory board member for Intellirod. Dr. Singh serves as the Chair of the DSMB for the BIFS-001 study. Ms. Murphy is an employee of Allergan, Inc., and holds stock and stock options in that company. Neither honoraria nor other forms of payment were made for authorship. This study was sponsored by Allergan, Inc., Irvine, CA. The Article Processing Charge was paid for by Allergan, Inc.
Funding Information:
Writing and editorial assistance was provided to the authors by Adrienne Drinkwater, PhD, and Kristin E. Larsen, PhD, of Peloton Advantage, Parsippany, N.J., and was funded by Allergan Inc., Irvine, Calif.
Publisher Copyright:
Copyright © 2015 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of The American Society of Plastic Surgeons. All rights reserved.
PY - 2015
Y1 - 2015
N2 - Background: A large, multicenter, 10-year observational study is comparing the long-term safety and effectiveness of Natrelle silicone breast implants versus saline implants or national norms. Methods: Women who underwent primary augmentation, revision-augmentation, primary reconstruction, or revision-reconstruction were invited to participate. Enrolled subjects had completed surgery and received one implant or matching implants. Baseline demographics, health, lifestyle, and surgical characteristics are presented here for adult subjects who underwent primary reconstruction or revision-reconstruction. Results: Of 5637 subjects who underwent reconstruction surgery (86.7% primary reconstruction; 13.3% revision-reconstruction), 5407 received silicone implants and 230 received saline implants; 72.9% received bilateral implants. Silicone implants were used in 96.2% who underwent primary reconstruction and in 94.1% who underwent revision-reconstruction. Median age was about 3 years lower in those who underwent primary reconstruction versus revision-reconstruction. Most subjects were white nonsmokers and had attended college. Hispanic subjects were more likely to receive saline implants for primary reconstruction. Across groups, the most common characteristics by implant type or procedure included smooth-surface implants (90.8%), mastectomy scar site (69.7%), and partial (59.2%) or complete (33.9%) submuscular placement. Implant size was larger for revision-reconstruction versus primary reconstruction, and incision size was larger for silicone versus saline implants in subjects undergoing primary reconstruction. Conclusions: This study provides an unprecedented look at a large subject sample. The data offer surgeons an opportunity to make informed decisions regarding the most appropriate implant attributes and surgical approaches for women who desire breast implants for primary or revisionary breast reconstruction.
AB - Background: A large, multicenter, 10-year observational study is comparing the long-term safety and effectiveness of Natrelle silicone breast implants versus saline implants or national norms. Methods: Women who underwent primary augmentation, revision-augmentation, primary reconstruction, or revision-reconstruction were invited to participate. Enrolled subjects had completed surgery and received one implant or matching implants. Baseline demographics, health, lifestyle, and surgical characteristics are presented here for adult subjects who underwent primary reconstruction or revision-reconstruction. Results: Of 5637 subjects who underwent reconstruction surgery (86.7% primary reconstruction; 13.3% revision-reconstruction), 5407 received silicone implants and 230 received saline implants; 72.9% received bilateral implants. Silicone implants were used in 96.2% who underwent primary reconstruction and in 94.1% who underwent revision-reconstruction. Median age was about 3 years lower in those who underwent primary reconstruction versus revision-reconstruction. Most subjects were white nonsmokers and had attended college. Hispanic subjects were more likely to receive saline implants for primary reconstruction. Across groups, the most common characteristics by implant type or procedure included smooth-surface implants (90.8%), mastectomy scar site (69.7%), and partial (59.2%) or complete (33.9%) submuscular placement. Implant size was larger for revision-reconstruction versus primary reconstruction, and incision size was larger for silicone versus saline implants in subjects undergoing primary reconstruction. Conclusions: This study provides an unprecedented look at a large subject sample. The data offer surgeons an opportunity to make informed decisions regarding the most appropriate implant attributes and surgical approaches for women who desire breast implants for primary or revisionary breast reconstruction.
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U2 - 10.1097/GOX.0000000000000406
DO - 10.1097/GOX.0000000000000406
M3 - Article
AN - SCOPUS:85042894691
SN - 2169-7574
VL - 3
JO - Plastic and Reconstructive Surgery - Global Open
JF - Plastic and Reconstructive Surgery - Global Open
IS - 8
M1 - e489
ER -